Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study
Overview
This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Newly diagnosed metastatic CRC or metastatic recurrence of CRC greater than 1 year from diagnosis at age >= 65y.
- Planning to undergo 1st line 5-FU based chemotherapy (as monotherapy [as 5-FU alone or capecitabine] or in combination with oxaliplatin and/or irinotecan +/- biologics).
- Estimated life expectancy >= 6 months.
- Patients must be able to read and comprehend English (for questionnaire completion).
- Ability to understand and the willingness to sign a written informed consent document.
- Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- > 10%) body weight change in the previous 12 months are eligible for this study.
Key Exclusion Criteria
A patient will not be eligible if any of the following criteria applies
- Patients enrolled on hospice.
- Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed >= 12 months prior to disease recurrence).
- Patients may not be receiving any other investigational agents.
- No untreated brain metastases. Patients with treated brain metastases are eligible.
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Observational
Sponsor(s)
Gary Morrow, University of Rochester NCORP Research Base
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